Everolimus tablets 5mg — Class III drug recall D-0026-2026
Ongoing recall by Endo USA, Inc., reported 2025-10-22, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
| Recall number | D-0026-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endo USA, Inc., Malvern, PA, United States |
| Recall initiated | 2025-09-05 |
| Classified | 2025-10-16 |
| Reported by FDA | 2025-10-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,041 cartons |
| Reason classes | specification failure |
| NDC | 49884-0125-91 |
| Lot numbers | 550172301 |
| Expiration dates | 2026-01-20 |
Product
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0026-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.